169 Participants Needed

MK-6194 for Vitiligo

Recruiting at 69 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme LLC
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called MK-6194 to see if it can help people with non-segmental vitiligo. The goal is to determine if MK-6194 can reduce the white patches on their skin by helping repigment these areas. Researchers will compare the results over several months.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain prohibited medications within specific timeframes before joining the study, so it's best to discuss your current medications with the study team.

Research Team

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for individuals with non-segmental vitiligo, which causes loss of skin color in blotches. Participants must have had the condition for at least 6 months and show a certain amount of facial and body depigmentation. Those with hands and feet involvement or other forms of vitiligo are not eligible.

Inclusion Criteria

You have a Total Vitiligo Area Scoring Index (T-VASI) of at least 4 at the time of screening and baseline.
I have widespread vitiligo for more than 6 months.
You have a BSA of at least 0.3% on your face with no pigmentation present.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous MK-6194 or placebo for up to 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may opt into continuation of treatment with MK-6194 regimen 1 or 2

Treatment Details

Interventions

  • MK-6194
Trial Overview The study tests MK-6194 against a placebo to see if it's better at improving the appearance of vitiligo on the face after 24 weeks. The main goal is to check how much this treatment can change the extent of skin color loss compared to no active treatment.
Participant Groups
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension: Dose 2Experimental Treatment2 Interventions
Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Group II: Extension: Dose 1Experimental Treatment1 Intervention
Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Group III: Base Study: Dose 2Experimental Treatment2 Interventions
Participants receive SC MK-6194 dose regimen 2.
Group IV: Base Study: Dose 1Experimental Treatment1 Intervention
Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
Group V: Base Study: PlaceboPlacebo Group1 Intervention
Participants receive an SC placebo regimen.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University